2024
Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema
Bressler S, Barve A, Ganapathi P, Beckmann K, Apte R, Marcus D, Baumane K, Agarwal S, Oleksy P, Reichstein D, Patel S, Ernest J, Dégi R, Gupta V, Kishino G, Kamei M, Loganathan S, Chaudhry N, Reichstein D, Tabassian A, Fine H, Sjaarda R, Marcus D, Barakat M, Dugel, P, Eichenbaum D, Dessouki A, Berger A, Angle B, Chang M, Patel S, Brown D, Thach A, Baker C, Gordon A, Mansour S, Fox G, Alfaro D, Davies J, Ghorayeb G, Stoller G, Johnson T, Nemcansky J, Rehak J, Studnicka J, Ernest J, Korda V, Veith M, Krzyzanek D, Kalvodova B, Stodulka P, Feltgen N, PD K, Grisanti S, Gamulescu M, Kellner U, Sekundo W, Dahlke C, Zeitz O, Baumane K, Laganovska G, Ozolina S, Vajas A, Seres A, Tsorbatzoglou A, Radnoti J, Kiss K, Gombos K, Degi R, Varsanyi B, Kerenyi A, Noge S, Muramatsu T, Kaga T, Oh H, Watanabe M, Oshima Y, Fujita H, Kishino G, Hanemoto T, Murata K, Kitaoka T, Saito I, Tanabe T, Ebihara N, Imaizumi H, Ishii K, Kamei M, Furuta M, Ojima A, Sawada O, Kawasaki T, Otake H, Doi N, Abe, K, Matsuda S, Kobayashi N, Yoshizumi Y, Budzinskaya M, Lebedev O, Eremina A, Zolotarev A, Izmaylov A, Samoylov A, Astakhov S, Astakhov Y, Shkvorchenko D, Narayanan R, Agarwal K, Rahul S, Natesh S, Gupta V, Panchal B, Kaza H, K M, Agrawal V, Elhence A, Behera U, Raj L, Mazumdar S, Kannan N, Yadav N, Vohra R, Aggarwal S, Sonawane A, Saravanan V, Chauhan R, Fluder E, Nawrocki J, Wylegala E, Zalewski D, Oleksy P, Borcz E. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema. JAMA Ophthalmology 2024, 142: 952-960. PMID: 39264599, PMCID: PMC11393752, DOI: 10.1001/jamaophthalmol.2024.3458.Peer-Reviewed Original ResearchBest-corrected visual acuityDiabetic macular edemaCentral subfield thicknessEarly Treatment Diabetic Retinopathy StudyAflibercept groupAntidrug antibodiesAdverse eventsWeek 8Aflibercept armMacular edemaIncidence of treatment-emergent adverse eventsPrimary outcomeBaseline BCVA letter scoreTreatment Diabetic Retinopathy StudyTreatment-emergent adverse eventsIncidence of adverse eventsConsecutive intravitreal injectionsDiabetic Retinopathy StudyRandomized clinical trialsType 2 diabetesStudy eyesSubfield thicknessDouble-MaskedIntravitreal injectionRetinopathy Study
2021
Effect of sustained-release long-acting intravitreal dexamethasone implant in patients of non-proliferative diabetic retinopathy undergoing phacoemulsification: A randomized controlled trial
Gupta P, Ram J, Kumar M, Agarwal A, Gupta V, Singh R, Bansal R, Katoch D, Dogra M, Gupta A. Effect of sustained-release long-acting intravitreal dexamethasone implant in patients of non-proliferative diabetic retinopathy undergoing phacoemulsification: A randomized controlled trial. Indian Journal Of Ophthalmology 2021, 69: 3263-3272. PMID: 34708785, PMCID: PMC8725102, DOI: 10.4103/ijo.ijo_749_21.Peer-Reviewed Original ResearchConceptsEarly Treatment Diabetic Retinopathy StudyDexamethasone drug delivery systemStandard of careIntravitreal dexamethasone implantLaser flare meterDexamethasone implantIntraocular pressureOptical coherence tomographyMacular thicknessIntraocular lensDiabetic retinopathyDexamethasone groupTreatment Diabetic Retinopathy StudyNon-proliferative diabetic retinopathyStatistically significant interactionCentral macular thicknessIOP scoreDiabetic Retinopathy StudyStandard of care groupVisual acuity scoresType 2 diabetes mellitusRescue interventionCo-primary outcomesFlare meterMacular edema
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